FDA in­spec­tion of Chi­na-based site mak­ing Co­herus' po­ten­tial new can­cer drug ends with three ob­ser­va­tions

Af­ter Covid-re­lat­ed de­lays that forced the FDA to de­lay its Chi­na-based in­spec­tions, Co­herus Bio­Sciences said to­day that its Chi­na-based part­ner Jun­shi Bio­sciences has now suc­cess­ful­ly com­plet­ed the re­quired pre-ap­proval in­spec­tion for its PD-1 tori­pal­imab, which is be­ing made at a site in Chi­na, with three ob­ser­va­tions.

“The Com­pa­ny be­lieves that the three ob­ser­va­tions re­ceived at the close of the FDA in­spec­tion are read­i­ly ad­dress­able and, to­geth­er with Jun­shi Bio­sciences, plans to sub­mit the re­sponse to the FDA in ear­ly June,” Co­herus said in an SEC fil­ing. The com­pa­ny did not dis­close the ob­ser­va­tions, but Co­herus’ stock price $CHRS fell by al­most 8% on Wednes­day.

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